Eloxatin

DRUG DESCRIPTION

ELOXATIN® (oxaliplatin for injection and oxaliplatin injection) is an antineoplastic agent with the molecular formula C8H14N2O4Pt and the chemical name of cis-[(1 R,2 R)-1,2cyclohexanediamine-N,N'] [oxalato(2-)-O,O'] platinum. Oxaliplatin is an organoplatinum complex in which the platinum atom is complexed with 1,2-diaminocyclohexane(DACH) and with an oxalate ligand as a leaving group.

ELOXATIN (oxaliplatin) Structural Formula Illustration

The molecular weight is 397.3. Oxaliplatin is slightly soluble in water at 6 mg/mL, very slightly soluble in methanol, and practically insoluble in ethanol and acetone.

Powder for solution for infusion

ELOXATIN is supplied in vials containing 50 mg or 100 mg of oxaliplatin as a sterile, preservative-free lyophilized powder for reconstitution. Lactose monohydrate is present as an inactive ingredient at 450 mg and 900 mg in the 50 mg and 100 mg dosage strengths, respectively.

Concentrate for solution for infusion

ELOXATIN is supplied in vials containing 50 mg, 100 mg or 200 mg of oxaliplatin as a sterile, preservative-free, aqueous solution at a concentration of 5 mg/ml. Water for Injection, USP is present as an inactive ingredient.

What are the possible side effects of oxaliplatin (Eloxatin)?

Some people receiving a oxaliplatin injection have had a reaction to the infusion within minutes after the medicine is injected into the vein. Tell your caregiver right away if you feel short of breath, confused, sweaty, itchy, or have diarrhea, chest pain, warmth or redness in your face, or feel like you might pass out.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side...

Read All Potential Side Effects and See Pictures of Eloxatin »

What are the precautions when taking oxaliplatin injection (Eloxatin)?

Before using oxaliplatin, tell your doctor or pharmacist if you are allergic to it; or to other platinum-containing products (e.g., cisplatin, carboplatin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, blood disorders, bone marrow problems, nerve disorders.

This drug may cause vision changes. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with...

Read All Potential Precautions of Eloxatin »


Eloxatin Consumer (continued)

SIDE EFFECTS: Diarrhea, changes in taste, mouth sores, nosebleeds, tiredness, headache, dizziness, or trouble sleeping may occur. Nausea and vomiting may be severe in some patients. Your doctor may prescribe medication to prevent or relieve nausea and vomiting. Eating several small meals, not eating before treatment, or limiting activity may help lessen some of these effects. If any of these effects persist or worsen, notify your doctor or pharmacist promptly.

Temporary hair loss may infrequently occur. Normal hair growth should return after treatment has ended.

Remember that your doctor has prescribed this medication because he or she has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

Tell your doctor right away if you have any serious side effects, including: pain/redness/swelling at the injection site, easy or unusual bruising/bleeding, mental/mood changes (e.g., depression), signs of too much body water loss (e.g., decreased urination, increased thirst, dry mouth), muscle cramps, weakness, pain/redness/swelling of the arms/legs, groin/calf pain, fainting.

Oxaliplatin can sometimes affect how your nerves work (peripheral neuropathy). Tell your doctor immediately if you develop: sensitivity to cold, trouble breathing/swallowing/speaking, jaw tightness, strange feeling in your tongue, eye pain, chest pressure, numbness/tingling/"pins and needles" sensation of the hands/feet/mouth/throat.

You may lessen these types of nerve problems by avoiding cold drinks and ice and by dressing warmly. Tell your doctor immediately if your nerve problems begin to interfere with your normal daily activities (e.g., walking, writing, eating).

Get medical help right away if any of these rare but very serious side effects occur: dry cough, shortness of breath, chest pain, black stools, vomit that looks like coffee grounds, vision changes (e.g., temporary vision loss), seizures, sudden confusion.

This medication can lower your body's ability to fight an infection. Notify your doctor promptly if you develop any signs of an infection such as fever, chills, or persistent sore throat.

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any of the following symptoms of a serious allergic reaction: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US -

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

PRECAUTIONS: Before using oxaliplatin, tell your doctor or pharmacist if you are allergic to it; or to other platinum-containing products (e.g., cisplatin, carboplatin); or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: kidney problems, blood disorders, bone marrow problems, nerve disorders.

This drug may cause vision changes. Do not drive, use machinery, or do any activity that requires clear vision until you are sure you can perform such activities safely.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose. Wash your hands well to prevent the spread of infections.

To lower your risk of getting cut, bruised, or injured, use caution with sharp objects like razors and nail cutters, and avoid activities such as contact sports.

Kidney function declines as you grow older. This medication is removed by the kidneys. Therefore, the elderly may be more sensitive to the side effects of this drug, especially diarrhea, loss of too much body water and potassium, low white blood cell count, tiredness, and fainting.

This medication is not recommended for use during pregnancy. It may harm an unborn baby. Discuss the risks and benefits with your doctor. If you become pregnant or think you may be pregnant, inform your doctor immediately. It is recommended that women of child-bearing age and men using this medication use two effective forms of birth control (e.g., condoms and birth control pills) to prevent pregnancy. Consult your doctor for more information.

It is not known if oxaliplatin passes into breast milk. Because of the possible risk to the infant, breast-feeding while using this drug is not recommended. Consult your doctor before breast-feeding.


Eloxatin Patient Information Including Side Effects

Brand Names: Eloxatin

Generic Name: oxaliplatin (Pronunciation: ox AL i PLA tin)

  • What is oxaliplatin (Eloxatin)?
  • What are the possible side effects of oxaliplatin (Eloxatin)?
  • What is the most important information I should know about oxaliplatin (Eloxatin)?
  • What should I discuss with my healthcare provider before receiving oxaliplatin (Eloxatin)?
  • How is oxaliplatin given (Eloxatin)?
  • What happens if I miss a dose (Eloxatin)?
  • What happens if I overdose (Eloxatin)?
  • What should I avoid while using oxaliplatin (Eloxatin)?
  • What other drugs will affect oxaliplatin (Eloxatin)?
  • Where can I get more information?

What is oxaliplatin (Eloxatin)?

Oxaliplatin is a cancer medication that interferes with the growth of cancer cells and slows their growth and spread in the body.

Oxaliplatin is used together with other cancer medications to treat colon and rectal cancer.

Oxaliplatin may also be used for other purposes not listed in this medication guide.

What are the possible side effects of oxaliplatin (Eloxatin)?

Some people receiving a oxaliplatin injection have had a reaction to the infusion within minutes after the medicine is injected into the vein. Tell your caregiver right away if you feel short of breath, confused, sweaty, itchy, or have diarrhea, chest pain, warmth or redness in your face, or feel like you might pass out.

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • numbness or tingly feeling in your hands, feet, throat, and around your mouth;
  • numbness or burning pain that interferes with daily activities;
  • increased sensitivity to cold temperatures and cold objects;
  • jaw or chest tightness, eye pain, strange feeling in your tongue, problems with speech or swallowing;
  • fever, diarrhea, vomiting, chills, body aches, flu symptoms, sudden cough;
  • increased thirst, dry mouth, urinating less than usual;
  • decreased vision;;
  • easy bruising or bleeding, unusual weakness; or
  • white patches or sores inside your mouth or on your lips.

Less serious side effects may include:

  • nausea, stomach pain, loss of appetite;
  • constipation;
  • tired feeling;
  • hair loss;
  • decreased taste sensation;
  • muscle pain;
  • headache;
  • sleep problems (insomnia);
  • swelling; or
  • back pain.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

What is the most important information I should know about oxaliplatin (Eloxatin)?

Do not use this medication without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

You should not receive this medication if you are allergic to oxaliplatin or similar medications such as carboplatin (Paraplatin) or cisplatin (Platinol).

Before receiving oxaliplatin, tell your doctor if you are allergic to any drugs, or if you have liver disease, asthma, or a nerve problem.

Receiving oxaliplatin can make you more sensitive to cold. This includes exposure to cold temperature and coming into contact with cold objects. To prevent discomfort avoid breathing in cold air, cover your skin in cold weather, wear gloves when handling cold objects, avoid air conditioning, and do not use ice or drink cold beverages.

Do not eat ice chips to ease mouth sores or nausea because you will be more sensitive to cold. Talk to your doctor about other ways to treat nausea or mouth sores.

Call your doctor if you have a serious side effect such as numbness or tingling, problems with speech or swallowing, chest tightness, fever with diarrhea or vomiting, increased thirst, decreased urination, easy bruising or bleeding, weakness, or mouth sores.

Oxaliplatin can lower blood cells that help your body fight infections. This can make it easier for you to bleed or get sick. Avoid being around others who are ill. Your blood will need to be tested on a regular basis. Your kidney and liver function may also need to be tested. Do not miss any scheduled appointments.

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